**9. Results of multicenter registries**

patients who are considered high risk for CEA because one or more of the following features:

as from peer-reviewed journals. The total number of procedures that have been performed till that date included 2,048 cases, with a technical success of 98.6%. The stroke rate was 3.08%. The 30-day post-procedure mortality rate was 1.37%. The registry was updated in 2003. The total number of stent procedures performed then became 12392 with a technical success rate of 98.9%. The Global Carotid Artery Stent Registry: In 1998, Wholey et al collected data from major interventional centers worldwide as well as from peer-reviewed journals. The total number of

Overall, there was TIA rate of 3.07%, minor strokes of 2.14%, major strokes of 1.20%, and procedure-related deaths of 0.64%. There were 6753 cases done without protection and which incurred a 5.29% rate of strokes and procedure-related deaths. In the 4221 cases with cerebral protection, there was a 2.23% rate of strokes and procedure-related deaths. The rate of neurologic events was

In the following years, several registries that were supported by the device industry were reported. These registries included

The Global Carotid Artery Stent Registry: In 1998, Wholey et al collected data from major interventional centers worldwide as well

procedures that have been performed till that date included 2,048 cases, with a technical success of 98.6%. The stroke rate was 3.08%. The 30-day post-procedure mortality rate was 1.37%. The registry was updated in 2003. The total number of stent procedures performed then became 12392 with a technical success rate of 98.9%. Overall, there was TIA rate of 3.07%, minor strokes of 2.14%, major strokes of 1.20%, and procedure-related deaths of 0.64%. There were 6753 cases done without protection and which incurred a 5.29% rate of strokes and procedurerelated deaths. In the 4221 cases with cerebral protection, there was a 2.23% rate of strokes and procedure-related deaths. The rate of neurologic events was 1.2%, 1.3%, and 1.7% at 1, 2, and 3 years, respectively.[9]

**10. Comparisons of stenting versus endarterectomy**

ipsilateral hypercapnic reactivity after CEA.[10]

for angioplasty and 3.3% for CEA (P<0.001).[11]

**11. The UK Leicester halted trial**

consent.[12, 13]

surgical group.[14]

periprocedural stroke.[15]

Markus et al studied the effect of carotid PTA compared to CEA on cerebral hemodynamics of symptomatic stenoses as reflected by CO2 reactivity. After PTA there was a significant improvement in ipsilateral hypercapnic reactivity. There was a similar improvement in

Update on Carotid Revascularization: Evidence from Large Clinical Trials

http://dx.doi.org/10.5772/57153

111

Golledge et al performed a systematic comparison of the 30-day outcome of angioplasty with or without stenting and CEA for symptomatic carotid disease reported in single-center studies, published between 1990 and 1999. All the results were in favor of CEA. Mortality within 30 days of angioplasty was 0.8% compared with 1.2% after CEA (P=0.6). The stroke rate was 7.1%

The most outstanding negative trial of carotid angioplasty was form Leicester Royal Infirmary. The study consisted of 23 patients with focal carotid territory symptoms and severe ICA stenosis (>70%) who were randomized to either CEA or CAS. However, only 17 had received their allocated treatment before trial suspension. All 10 CEA operations proceeded without complication, but 5 of the 7 (71.4%) patients who underwent CAS had a stroke, 3 of which were disabling at 30 days. The Data Monitoring Committee invoked the stopping rule and the trial was suspended. The investigators and the Ethics Committee subsequently decided that the trial should not be restarted even in an amended format because of problems with informed

The CAVATAS (Carotid and Vertebral Artery Transluminal Angioplasty Study), was the first randomized trial of CEA versus CAS. 504 patients were randomized from 22 centers in between 1992 and 1997. The majority of patients had recently symptomatic lesions. Only 26% of the angioplasty patients received a stent. The rates of major outcome events within 30 days of first treatment did not differ significantly between endovascular treatment and surgery (6.4% vs. 5.9%, respectively, for disabling stroke or death; 10.0% vs. 9.9% for any stroke lasting more than 7 days, or death). (Figure 21) At 1 year after treatment, restenosis was more usual after endovascular treatment (14%vs. 4%, p<0.001). Complications of cranial nerve injury and myocardial ischemia were only reported in the surgical group. The trial described rates of death and disabling stroke after 3 years of 14.3% in the endovascular group and 14.2% in the

Crawley et al compared cerebral hemodynamics and microembolization during CAS versus CEA using TCD. The period during which the ICA was occluded by PTA balloon or by clamp during CEA was timed. Ischemic time was defined as the period during which mean MCA velocity fell to a third or less of baseline. CEA resulted in significantly longer occlusion time and ischemic time than PTA. There were significantly more microembolic signals during PTA than during CEA. There was no correlation between any of the parameters measured and

In the following years, several registries that were supported by the device industry were reported. These registries included patients who are considered high risk for CEA because one or more of the following features:



**Table 3.** Carotid stent industry-supported high-risk registries
